As a chronic and incurable disease, diabetes mellitus requires continuing care that lasts throughout the life of the patient. Both caregivers and patients alike are expected to play an active role in managing diabetes, regardless of form, whether Type 1, Type 2, gestational, or other. Diabetes patients are typically coached by their caregivers on lifestyle modification and educated to understand the affects of diet, especially carbohydrates, body weight, physical activity, medications, and stress on their diabetic condition. Diabetes patients are also trained and encouraged to regularly test their blood glucose levels with the assistance of a portable glucose meter (“glucometer”). In addition, medication-treated patients learn to undertake daily self-administration of medications and, where appropriate, determine corrective medication dosing to counteract postprandial glycemic rise. All diabetes patients are expected to document their self-care in a daily diary that typically chronicles their daily self-monitored blood glucose values, medications, physical activity, and dietary intake.
In turn, caregivers follow their diabetes patients on a periodic basis and work to ensure their compliance with the consensus guidelines and mandatory targets (CG&MT), which have been formulated and are regularly updated by the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE), as well as the American Diabetes Association (ADA). At each patient consultation, a caregiver may evaluate the patient's daily diary to identify patterns in the pre-meal data, which can include examining particular examples of the patient's actions to determine underlying causes for any outcomes suffered, above all, episodes of hypoglycemia. Additionally, the caregiver will normally test the patient's level of glycated hemoglobin (“A1c”) to establish accord with the current CG&MT target for well-managed diabetes. As needed, the caregiver may adjust the patient's oral anti-diabetic medications or insulin dosing to hopefully move the patient's blood glucose and A1c levels closer to the mandated targets.
The roles respectively performed by caregivers and their diabetic patients form a “circle of care” that requires each patient to provide their own data and do those actions necessary that together allow the caregivers to effectively manage the patient's diabetic condition. At a minimum, each patient is expected to self monitor their blood glucose levels and comply with each caregiver's instructions. Obversely, the caregivers are expected to monitor the patient's condition and provide apt guidance through changes in medications and lifestyle as needed to achieve perfect diabetes control as mandated in the various guidelines.
Notwithstanding, the circle of care generally remains incomplete. Conventional diabetes management efforts are in practice remarkably retrospective due to the significant focus on past patient condition, as seen through the patient's self-monitored blood glucose values that ordinarily extend back over several prior months. In turn, armed at best with the historical values of blood glucose testing, as sometimes confirmed by A1c results, a caregiver endeavors to control the future direction of ongoing diabetes treatment typically for the next several months until the next consultation. This control is exercised chiefly by making adjustments to medications, typically focused on insulin, with the intent of somehow moving patient blood glucose levels and A1c to target, and often without demanding data more reflective of the patient's true condition at the time of consultation.
Some types of conventional glucometers attempt to bridge the gap in the circle of care by assisting patients in their own between-consultation diabetes self-management efforts. Basic glucometers merely calculate and display blood glucose levels by reading a disposable test strip upon which the patient has placed a drop of blood. However, so-called “smart” glucometers typically include an internal memory that electronically records the results of each blood glucose test, along with the date and time of testing. The stored blood glucose data can then be made available for download to a personal computer. In addition, when available, onboard software can calculate an average of recent blood glucose levels and identify trends and patterns in the blood glucose data. Notwithstanding, the decision on whether diabetes medication dosing or other changes are appropriate remains solely at the discretion of the patient or follow-on caregiver consultation.
The incompleteness of the circle of care contributes to the dilemma faced by caregivers in managing diabetes, which suggests that satisfactory glycemic control is seemingly only achievable with unsatisfactory risk of hypoglycemia, as well as the converse. The CG&MT recommends a fasting blood glucose level of less than 110 mg/dL (non-fasting less than 140 mg/dL) and A1c between 6% and 7%, with patients generally being asked to strive for A1c of less than 7% (and less than 6.5% according to other standards). Achieving these goals, however, carries the adverse consequence of increasing the risks of treatment-related hypoglycemia, which caregivers counter by changing diet or medication dosing that then shifts that patient's blood glucose level outside the CG&MT target range. Consequently, a self-reinforcing vicious cycle is formed, as increased medication dosing to reduce glycemic values into mandated target ranges results in increased hypoglycemic risk that a patient must counteract by eating more with an ensuing gain in body weight that induces further diabetes medication dosing change.
Therefore, a need remains for providing an improved approach to glycemic control that shifts the focus of diabetes management efforts away from retrospective blood glucose histories, such as stored on a glucometer, to recent and representative glycemic indications that better tie caregiver efforts and glucose management to actual, realized and timely patient need.